Single use lancet assembly

ABSTRACT

A single use lancet device having a housing, with an open interior and an access opening defined therein, a lancet, with a body and a piercing tip, and disposed in the open interior of the housing so as to move between a cocked orientation and a piercing orientation, a driving assembly structured to move the lancet into the piercing orientation, and a restrictor assembly having a shoulder element and a restrictor panel operatively associated with the lancet and the housing and structured to pass over the restrictor panel upon the lancet moving from its cocked orientation to its piercing orientation, and to abut the restrictor panel upon attempted movement of the lancet back into its cocked orientation after movement into the piercing orientation, thereby preventing the lancet from moving back into the cocked orientation and preventing re-use of a contaminated piercing tip.

CLAIM OF PRIORITY

The present application is a Continuation-In-Part application ofpreviously filed, now pending application having Ser. No. 09/903,877which was filed on Jul. 10, 2001, which is a continuation-in-part patentapplication having Ser. No. 09/432,351 which was filed on Nov. 2, 1999and which issued as U.S. Pat. No. 6,258,112 on Jul. 10, 2001, both ofwhich are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a single use lancet assembly which issubstantially compact, yet effective for piercing a patient's finger orother body part to obtain a blood sample. The single use lancet deviceis further configured to be substantially safe to transport and toensure that subsequent uses of a contaminated lancet tip cannot occur.

2. Description of the Related Art

Lancets are commonly utilized instruments which are employed both inhospitals and other medical facilities, as well as by privateindividuals, such as diabetics, in order to prick or pierce a patient'sskin, typically on a finger of a patient, thereby leading to thegeneration of a blood sample which can be collected for testing. Becauseof the wide spread use of such lancets, there are a variety of lancetdevices which are available for utilization by patients and/orpractitioners in a variety of different circumstances.

For example, a typical lancet may merely include a housing with a sharppiercing tip that is pushed into the patient's skin. More commonly,however, lancet devices, which house a piercing tip and/or a lancet,have been developed which effectively encase and fire the lancet intothe patient's skin, thereby eliminating the need for the person takingthe sample to actually push the lancet tip into the skin.

Within the various types of specialized lancet devices, one variety aretypically configured for multiple and/or repeated uses, while anothercategory is particularly configured for single use, after which theentire device is disposed of. Looking in particular to the single use,disposable lancet devices, such devices typically include a housingwhich contains and directs or drives a piercing tip into the patient'sskin, and which is disposed of along with the used lancet. Naturally, soto make such disposable devices cost effective for frequent use, suchdevices tend to be rather simplistic in nature providing only asufficient mechanism for firing, and not overly complicating the designso as to minimize that cost.

While existing single use devices are generally effective for achievingthe piercing of the skin required for effective operation, such singleuse, disposable devices typically do not incorporate a large number ofsafety features to ensure the safe use and disposal of the device. Forexample, one primary area of safety which must be addressed with alllancet devices pertains to the purposeful and/or inadvertent reuse of acontaminated lancet. Unfortunately, most currently available single uselancet devices are configured such that after a use thereof has beenachieved, it is possible for a patient to re-cock the device, therebyallowing for a subsequent, inappropriate use.

As a result, it would be highly beneficial to provide a single uselancet device which is substantially compact and disposable, can bemanufactured in a substantially cost effective manner, and whichnevertheless is substantially safe to utilize, affirmatively preventingre-use, once contaminated.

SUMMARY OF THE INVENTION

The present invention relates to a single use lancet device configuredto pierce a patient's skin and be useable only a single time, therebypreventing reuse of a contaminated lancet piercing tip. In particular,the present single use lancet device includes a housing having an openinterior area and an access opening defined therein. The housing ispreferably compact and includes a lancet disposed within its openinterior.

Looking to the lancet, it is preferably of the type which includes abody and a piercing tip. It is the piercing tip which includes thepointed configuration structured to penetrate or pierce a patient's skinfor the drawing of blood. Moreover, the lancet is cooperatively disposedwithin the open interior of the housing such that the lancet may movebetween at least a cocked orientation and a piercing orientation whereinthe patient's skin is penetrated by the piercing tip.

Also operatively associated with the lancet is a driving assembly. Thedriving assembly is structured to move or drive the lancet, at leasttemporarily, into the piercing orientation from the cocked orientation.Preferably, however, the device is configured such that the cockedorientation is generally maintained until affirmatively released by auser. Along these lines, the present single use lancet device alsoincludes an actuation button operatively associated with the lancet. Theactuation button is structured to protrude from the housing, at leastwhen the lancet is disposed in the cocked orientation, so as to beeffectively actuatable. When the lancet is in the cocked orientation,the actuation assembly maintains the lancet in that cocked orientation,however, when it is actuated, such as by being pushed inward, the lancetis released from the cocked orientation and the driving assembly propelsthe lancet at least temporarily into its piercing orientation whereinthe piercing tip protrudes through the access opening of the housing.

In order to ensure that lancet device can only be used a single time,the present single use lancet device further includes abutment structurecooperatively disposed between the housing and the lancet. The abutmentstructure is configured to prevent the lancet from moving into thecocked orientation after movement into the piercing orientation.Preferably, the abutment structure includes a shoulder element and arestrictor panel operatively associated with the lancet and the housing.In particular, the shoulder element is structured to pass over therestrictor panel when the lancet moves from its cocked orientation toits piercing orientation. Conversely, however, when a user attempts tomove the lancet back into the cocked orientation after it moved into thepiercing orientation, the restrictor panel abuts the shoulder elementpreventing further movement. As a result, movement of the lancet intothe cocked orientation is prevented once the lancet has been used asingle time, and subsequent uses of a contaminated lancet are prevented.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention,reference should be had to the following detailed description taken inconnection with the accompanying drawings in which:

FIG. 1 is a perspective illustration of an embodiment of the single uselancet device of the present invention;

FIG. 2 is a side cross section view of the single use lancet device ofthe present invention in an unused, initially un-cocked orientation;

FIG. 3 is a side cross section view of the single use lancet device ofthe present invention in a cocked orientation;

FIG. 4 is a side cross section view of the single use lancet device ofthe present invention after it has moved into a piercing orientationfrom the cocked orientation;

FIG. 5 is a front cross section view of the single use lancet device ofthe present invention; and

FIG. 6 is a side cross section view of another embodiment of the singleuse lancet device of the present invention after the lancet has movedfrom the cocked orientation through the piercing orientation.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Shown throughout the Figures, the present invention is directed towardsa single use lancet device, generally indicated as 10. In particular,the single use lancet device 10 of the present invention includes ahousing, generally indicated as 20. The housing 20 is preferablysubstantially small and compact, and may be made of one or a pluralityof segments, preferably of a generally rigid, disposable material, suchas plastic. The housing 20 includes an at least partially open interior28 and at least one access opening 22 defined therein. The open interior28 of the housing 20 is preferably sized and configured to effectivelyreceive a lancet, generally 30 therein.

In particular, the lancet device 10 of the present invention alsocomprises a lancet 30. The lancet 30 preferably includes a body 32 and apiercing tip 34. The piercing tip 34 is what will be used to pierce aperson's skin so as to draw blood to be utilized for a sample and ortest procedure. Moreover, the body 32 may be the shaft of the piercingtip 34 and/or an additional structure such as that depicted in theFigures. Regardless, however, the lancet 30 is structured to move withinthe open interior 28 of a housing 20, preferably at least between acocked orientation, as depicted in FIG. 3, and a piercing orientationwherein the piercing tip 34 of lancet 30 at least temporarily protrudesthrough the access opening 22.

Looking in further detail to the illustrated lancet device 10, and thepath of movement of the lancet 30 within the housing 20, when the lancetdevice 10 is initially obtained for use, the lancet 30 is preferablymaintained in an un-used, initially un-cocked and pre-fired orientation,as best seen in FIG. 2. In this initially un-cocked and pre-firedorientation a protective cover 40 preferably extends into the openinterior 28 of the housing 20 so as to at least partially and removablycover the piercing tip 34 of the lancet 30, thereby maintaining thesafety and sterility of the piercing tip 34 when not being used. In thisregard, the protective cover 40 may be formed from a variety ofpreferably rigid materials and is structured to protrude from thehousing 20. Furthermore, the protective cover 40 may include an enlargedhead 42 configured to facilitate grasping thereof.

Preferably utilizing the protective cover 40, the protective cover 40 isstructured to be pushed inwardly into the housing by a user, as depictedby the arrows on FIG. 2, thereby pushing the lancet 30 further into thehousing 20. Such pushing of the lancet 30 into the housing 20 results ina positioning of the lancet 30 in its cocked orientation, bestillustrated in FIG. 3. Once in the cocked orientation, the protectivecover 40 is then structured to be removable from the piercing tip 34,such as by a twisting thereof, thereby leaving the piercing tip 34completely exposed for use.

The single use lancet of the present invention further includes adriving assembly, generally 38. The driving assembly 38 is particularlyconfigured to move the lancet 30 at least temporarily into its piercingorientation wherein the piercing tip 34 protrudes through the accessopening 22 of the housing 20 a desired amount. In particular, ifdesired, a depth adjustment structure could be positioned at the accessopening to control the amount which the piercing tip protrudes from thehousing 20. For example, a threaded washer type element could beadjustably secured to the housing 20 in generally surrounding relationto the access opening 22.

Looking further to the driving assembly, preferably the driving movementoccurs when the lancet 30 is released from its cocked orientation. Inthe illustrated embodiment, the driving assembly 38 includes a biasingelement operatively disposed between the lancet 30 and the housing 20.Moreover, in the illustrated embodiment a spring is preferably utilized,however, it is recognized that a variety of other driving assemblies canbe utilized, including a wedge assembly, a hammer type assembly and/or aresilient material plate, segment or extension, all of which may beconfigured to move the lancet 30 from the cocked orientation into thepiercing orientation. Further, it is preferred that based upon thesizing of the housing 20 and the nature and size of the driving assembly38, that after the lancet 30 has moved into the piercing orientationwherein the piercing tip 34 protrudes through the access opening 22, thelancet tends to be retracted back into the housing, as best illustratedin FIG. 4. As a result, the used piercing tip 34 is effectivelyconcealed within the housing 20 subsequent to usage, protecting againstinadvertent engagement between a person and the used piercing tip 34.

In order to retain, and subsequently effectively release the lancet 30from its cocked orientation, the single use lancet 10 of the presentinvention further includes an actuation assembly, generally, 50.Although a variety of different actuation assemblies may be incorporatedso as to retain and then release the lancet 30 from its cockedorientation, which in the illustrated embodiment allows the drivingassembly to be released from its compressed orientation, the actuationassembly 50 includes an actuation button 52. In the illustratedembodiment, the actuation button 52 is structured to at leasttemporarily protrude from the housing 20, such as through an actuationaperture 24. Furthermore, the actuation button 52 is preferably secured,either directly or indirectly to the lancet 30, so as to generallyrestrict movement of the lancet 30 from the cocked orientation when itprotrudes from the housing 20. As a result, the cocked orientation ismaintained while the actuation button protrudes from the housing 20.Specifically, in the illustrated embodiment, the actuation button 52extends from the body 32 of the lancet 30 by a biased segment, and assuch, by abutting the housing 20 within the actuation opening 24,movement of the lancet 30 from the cocked orientation is prevented.When, however, the actuation button 52 is actuated, such as by beingpushed inwardly, into the housing, it is at least temporarily concealedwithin the housing 20, removing the abutting engagement and allowing thelancet 30 to freely move within the housing 20, at least temporarilyinto the piercing orientation. Although the preceding defines theillustrated actuation assembly, it is understood that a variety ofalternative actuation assemblies, such as including separate elements toretain and to release the lancet may also be provided, and or includingstructures which are actually part of the driving assembly and/or remainat least partially exposed and actuatable at all times, may also beprovided.

Looking in particular to FIG. 5, movement of the lancet 30 through thehousing 20 is preferably maintained in a substantially linear path by aguide assembly. In the illustrated embodiment, the guide assemblyincludes at least one guide ridge 33 protruding from the body 32 of thelancet 30, and at least one corresponding guide track 25 structured tomovably receive the guide ridge 33 therein. The guide track 25preferably extends at least partially along a length of the openinterior 28 of the housing 20 so as to maintain the guide ridge 33effectively therein during a necessary range of motion of the lancet 30.As depicted in FIG. 5, preferably a pair of guide ridges 33 are disposedon opposite sides of the lancet body 32, with a corresponding pair ofoppositely disposed guide tracks 25 being defined in the housing. It isof course, however, understood that the guide tracks 25 need notnecessarily be directly defined in the housing 20, but may be additionalelements secured therein, and conversely the guide track(s) may bedefined in or on the lancet body 32, with the guide ridge(s) extendinginwardly from the housing 20.

The single use lancet 10 of the present invention further includes arestrictor assembly, generally 60. The restrictor assembly 60 isstructured to substantially prevent the lancet 30 from moving back intothe cocked orientation of FIG. 3 after it has moved, even momentarily,into the piercing orientation wherein a patient's skin may be piercedand the piercing tip 34 become contaminated. In this regard, the cockedorientation may be defined by the lancet being positioned such thatactuation of the actuation assembly causes the driving assembly to urgethe lancet into the piercing orientation. In the illustrated embodiment,the restrictor assembly 60 is structured such that when the lancet 30 isdisposed in the initially un-cocked orientation, as best seen in FIG. 2,movement of the lancet 30 back into the cocked orientation caneffectively result despite the restrictor assembly 60. After, however,the lancet 30 has moved into its piercing orientation wherein thepiercing tip 34 has protruded through the access opening 22 of thehousing 20, the restrictor assembly is configured such that the lancet30 can no longer be pushed back into the cocked orientation. As aresult, a patient, can neither accidentally nor purposefully reuse thesingle use lance 10 of the present invention after it has been fired.

In the illustrated embodiment, the restrictor assembly 60 includes anabutment structure cooperatively disposed between the housing 20 and thelancet 30. The abutment structure is configured to physically preventmovement of the lancet back into the cocked orientation. Preferably, theabutment structure comprises a shoulder element 62 and a restrictorpanel 64 configured to freely pass one another when the lancet 30 movesfrom the cocked orientation to the piercing orientation, but alsoconfigured to abut one another upon attempted movement of the lancet 30back into the cocked orientation after it has moved into the piercingorientation. Looking to FIG. 4, the illustrated shoulder element 62includes an at least partially slopped and preferably biasedconfiguration, such as an elongate biased finger that at least partiallyretracts inward towards the body 32 of the lancet 30 so as to facilitatepassage thereof past the restrictor panel 64. In this regard, preferablymating slopped surfaces are provided on the shoulder element 62 and therestrictor panel 64, thereby facilitating the sliding passages past oneanother, and indeed, promoting an at least partial retraction of theshoulder element 62 to further facilitate this passage past one another,upon movement of the lancet 30 in a first direction towards the accessopening 22 of the housing 20. The shoulder element 62 is also, however,structured to generally expand after it has passed the restrictor panel64, such as back into its normal unretracted and/or un-compressedorientation, such that it will abut the restrictor panel 64 uponattempted movement of the lancet 30 in a second direction opposite theaccess opening 22 of the housing 20.

Although an opposite configuration could be just as effectivelyutilized, in the illustrated embodiment, the biased finger 62 of theshoulder element extends from the lancet 30, preferably generally towardthe piercing tip 34 of the lancet 30., while the restrictor panel 64protrudes from the housing 20, extending into the open interior 28 ofthe housing 20. Along these lines, the restrictor panel 64 includes aprotruding element preferably with the aforementioned sloppedconfiguration which downwardly slopes away from the piercing tip 34 ofthe lancet 30 facilitating the aforementioned sliding passage past theshoulder element 62.

So as to provide generally secure movement restriction through effectiveabutment, both the shoulder element 62 and the restrictor panel 64 eachpreferably include abutment surfaces 63 and 65, respectably. Theabutment surfaces 63 and 65 are structured to generally engage and abutone another, as best illustrated in FIG. 4, thereby preventing movementof the lancet 30 back into the cocked orientation. In the illustratedembodiment, the abutment surfaces 63, 65 are generally flat, although itis recognized that interlocking fingers or wedges, and/or other types ofengaging structures that prevent relative movement in at least onedirection could also be effectively utilized.

Addressing further the restrictor assembly of the present invention, itis understood that a variety of different restrictor assemblies may beeffectively utilized which prevent movement of a lancet 30 back into acocked orientation after the lancet 30 has moved sufficiently forwardand/or has moved into the piercing orientation. As such, the embodimentillustrated in FIGS. 2 through 5 is merely a single illustration of apreferred contemplated embodiment, and other alternative embodiments arealso considered within the scope of the restrictor assembly of thepresent invention. By way of example, and looking specifically to FIG.6, the actuation button 52 itself may comprise part of the restrictorassembly. In such an embodiment, a restrictor panel 25 is defined in thehousing 20, and the actuation button 52 as part of the biased finger ofthe shoulder element, includes an abutment surface 54 which engages aconfronting surface of the restrictor panel 25. In such an embodiment,the initially un-cocked orientation provides for the actuation button 52to be initially disposed rearward of the restrictor panel 25 so as topermit movement of the lancet 30 at least initially into the cockedorientation. Moreover, in this embodiment, the previous embodiment,and/or any other alternative embodiment, if desired, the protectivecover 40 may be equipped with an interior shield segment or otherconfiguration which extends into the housing and maintains the biasedfinger of the shoulder element 62, or another component of therestrictor assembly, in a generally compressed and/or retractedorientation until the protective cover 40 is removed. As a result, insuch an embodiment, so long as the protective cover 40 is maintained onthe piercing tip 34, the lancet 30 is always able to return the cockedorientation. Preferably, however, re-positioning of the protective coveronto the piercing tip in such a manner as to be able to “reset” thelancet 30, allowing to move once again into the cocked orientation willbe prevented.

Since many modifications, variations and changes in detail can be madeto the described preferred embodiment of the invention, it is intendedthat all matters in the foregoing description and shown in theaccompanying drawings be interpreted as illustrative and not in alimiting sense. Thus, the scope of the invention should be determined bythe appended claims and their legal equivalents.

Now that the invention has been described,

1. A single use lancet device comprising: a housing; a lancet; saidlancet including a piercing tip; said lancet at least partially disposedin said housing and structured to move at least between a cockedorientation and a piercing orientation; a biasing element structured tomove said lancet at least temporarily into said piercing orientation; anactuator structured to be actuated by a user so as to result in saidbiasing element moving said lancet at least temporarily into saidpiercing orientation; and a restrictor assembly independent of saidbiasing element and structured to engage said lancet and thereby preventsaid lancet from being moved back into said cocked orientation aftermovement of said lancet at least temporarily into said piercingorientation even if an implement pushes said lancet.
 2. A single uselancet as recited in claim 1 wherein said biasing element comprises aspring.
 3. A single use lancet as recited in claim 1 wherein saidactuator comprises a button structured to protrude from said housingwhen said lancet is disposed in said cocked orientation.
 4. A single uselancet as recited in claim 1 wherein said restrictor assembly comprisesan abutment structure cooperatively disposed between said housing andsaid lancet and structured to prevent said lancet from moving into saidcocked orientation after movement into said piercing orientation.
 5. Asingle use lancet as recited in claim 4 wherein said abutment structurecomprises a shoulder element and a restrictor panel, said restrictorpanel and said shoulder element structured to pass one another upon saidlancet moving from said cocked orientation to said piercing orientation,and to abut one another upon attempted movement of said lancet into saidcocked orientation after movement into said piercing orientation.
 6. Asingle use lancet as recited in claim 5 wherein said shoulder element isstructured to move relative to said restrictor panel so as to facilitatepassage of said restrictor panel and said shoulder element past oneanother in a first direction corresponding movement of said lancet fromsaid cocked orientation to said piercing orientation, and to blockmovement of said restrictor panel in a second direction generallyopposite said first direction subsequent to said passage past oneanother in said first direction.
 7. A single use lancet as recited inclaim 6 wherein said shoulder element comprises a biased fingerextending from said lancet, and said restrictor panel comprises aprotruding element protruding from said housing.
 8. A single use lancetas recited in claim 7 wherein said protruding element includes a slopedconfiguration which downwardly slopes away from said piercing tip ofsaid lancet so as to facilitate passage thereof past said biased fingerupon said lancet moving in a first direction towards said accessopening.
 9. A single use lancet as recited in claim 4 wherein saidabutment structure further comprises said actuator structured to releasesaid lancet from said cocked orientation.
 10. A single use lancet asrecited in claim 1 further comprising a protective cover structured toat least partially and removably cover said piercing tip of said lancetat least prior to movement of said lancet into said cocked orientation.11. A single use lancet device comprising: a housing; a lancet; saidlancet disposed at least partially in an interior of said housing andstructured to move relative to said housing; a biasing elementstructured to move said lancet into a second position relative to saidhousing wherein said lancet pierces a patient's skin from a firstposition relative to said housing wherein said lancet is disposedimmediately prior to being moved by said biasing element towards andinto said second position; an actuator structured to be actuated by auser so as to result in said biasing element moving said lancet; and anabutment structure independent of said biasing element and cooperativelydisposed between said housing and said lancet, said abutment structurestructured to prevent movement of said lancet back into said firstposition relative to said housing after movement of said lancet intosaid second position relative to said housing even if an implementpushes said lancet towards said first position relative to said housing.